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New Treatment Modalities for Localized Prostate Cancer
Sponsor: Fundacion IMIM
Summary
The purpose of this study is to evaluate the effectiveness of four of the nowadays most established primary treatments for patients with clinically localized prostate cancer (active surveillance, robot-assisted radical prostatectomy, intensity-modulated radiotherapy, and real-time brachytherapy) at short-, mid- and long-term follow-up. The primary aim is assessing the impact of treatments' side effects on patient's quality of life. As secondary objectives, biochemical disease-free survival, overall survival, and prostate cancer-specific survival will also be assessed.
Official title: Comparative Effectiveness of New Treatment Modalities for Localized Prostate Cancer
Key Details
Gender
MALE
Age Range
50 Years - 75 Years
Study Type
OBSERVATIONAL
Enrollment
480
Start Date
2014-04
Completion Date
2027-12
Last Updated
2025-03-12
Healthy Volunteers
No
Conditions
Interventions
Active Surveillance
It consists on monitoring the cancer with regular tests including PSA, blood test and digital rectal examination every 6 months, a magnetic resonance imaging and prostate biopsy at the first year, and based on clinical decision thereafter. If there was a change on the results, the patient is considered for treatment.
Robot-Assisted Radical Prostatectomy
It consists on the removal of the prostate gland and seminal vesicles with neurovascular preservation whenever anatomically and oncologically possible, with the Da Vinci procedure. Access is made through 5 or 6 small incisions, less than 1 cm. An extended pelvic lymph node dissection is performed when the risk estimation of node involvement is above the 5%. After surgery, the patient will be hospitalized for about 3 days and will probably resume his work activity between 3 and 5 weeks.
Intensity-Modulated Radiotherapy
Patients in this group undergo volumetric modulated arc therapy under daily image-guided radiation therapy in the supine position. Radiation is delivered in 2-3 Gy daily fractions, 5 days per week, with a prescription dose of 60-70 Gy to the prostate.
Real-time brachytherapy
Patients in this group receive I125 permanent seeds (low dose rate). The images are obtained with a transrectal ultrasound probe and are transferred to a planning system for calculating the number and position of the seeds. The prescrption dose is 145 Gy to the reference isodose (100%).